Within the Department of Neurology’s Clinical Research Office and reporting to the Research manager with a focus on neurocritical care, the Clinical Research Coordinator (CRC) will lead efforts in the execution of research studies within the scope of the established study protocol(s) assigned. These activities include, but are not limited to, study start up, patient screening, eligibility determination, registration and other protocol and subject milestones. The CRC will also be the primary poin... more details
Within the Department of Neurology’s Clinical Research Office and reporting to the Research manager with a focus on neurocritical care, the Clinical Research Coordinator (CRC) will lead efforts in the execution of research studies within the scope of the established study protocol(s) assigned. These activities include, but are not limited to, study start up, patient screening, eligibility determination, registration and other protocol and subject milestones. The CRC will also be the primary point of contact for the sponsor on all communications and management of all study documentation. The CRC will have direct patient contact and will be responsible for managing multiple clinical research projects/trials and will serve as a back up to other clinical research coordinators within the clinical research team in Neurology. The CRC will work collaboratively with postgraduate students. Some studies may require on call rotational support on weekends/after normal business hours. Subjects will be recruited mainly in the New Haven campus but may be recruited from other Yale Neurology locations within the state of Connecticut. Exemplary time and attendance. Ability to be flexible in schedule to attend to study needs and subject recruitment and work as a team with other clinical research coordinators. 1. Works closely with investigators and other study team members including the project manager, for projects or programs of a small size or sections of medium projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters. 2. Interprets research business needs and translates them into application and operational requirements for a specific area(s) of research. Develops necessary tools and workshops to successfully elicit requirements. 3. Critically evaluates information gathered from multiple sources – research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials. 4. Analyzes data with standard methods, interprets the results, and provides written summary and reporting of data analysis. Develops reporting modules, ad-hoc reports and related reporting tools. Conducts research, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases. 5. Develops and maintain documentation and libraries on key processes.6. Assesses risk and ensures compliance with research protocols/guidelines, university procedures, and third party regulations. 7. Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members. 8. Performs or assists with research compliance audits or self-assessments. 9. Communicates effectively the perspective of business opportunities, needs, and risks. Bachelor’s degree in a related field and one year of related work experience in the same job family or an equivalent combination of demonstrated experience and education. Ability to be knowledgeable in regional and federal regulations with the ability to perform independent decision-making on a daily basis.
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